InfectionPhase 2STIFLE-RISKNCT04473924
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
A Phase 2 study testing Mycophenolate Mofetil in people with Infection and Transplant;Failure,Kidney, run by University of California, San Francisco at 1 site in United States.
Trial summary
Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Transplant;Failure,Kidney
- What is being tested?
- Mycophenolate Mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
- Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit
Who cannot join
- Evidence of rejection on routine six month post-transplant biopsy
- Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
- Are or are planning to become pregnant, due to inability to take mycophenolate
- Are marginally housed, due to concerns regarding routine follow-up
- Are actively participating in a different interventional trial that may affect immunosuppression dosing
- Are unwilling to consent to participate
Show all 10Show fewer
- Institutionalized individuals or prisoners
- Are actively abusing illicit drugs or alcohol
- Have a history of poor or doubtful compliance (e.g., frequently missed appointments)
- Have cognitive impairment prohibiting participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.
- Conditions
- Infection, Transplant;Failure,Kidney
- Being tested
- Mycophenolate Mofetil
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Cellcept
Body surface area-based dosing of mycophenolate
Also called Cellcept
Standard (fixed) dosing of mycophenolate
| Study group | Role | What they receive |
|---|---|---|
| Body surface area-based mycophenolate dosing | Experimental | Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing. Receives: Drug: Mycophenolate Mofetil |
| Standard (fixed) dosing | Active comparator | Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily. Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
Assess the ratio of participants screened to enrolled into the study
Measured: 6 months
Secondary outcomes (4)
Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate
Assess the rate of dropout from the study
Measured: 6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Collect pilot data on number of overall hospitalizations
Measured: 6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Collect pilot data on infectious-related hospitalizations
Measured: 6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Collect pilot data on incidence of leukopenia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study startJul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Study has never started as sponsor did not approve for funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Ku, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473924
- Sponsor's protocol ID
- 20-31500
- Acronym
- STIFLE-RISK
- Status last verified
- May 2022
- First submitted
- 13 Jul 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
- ClinicalTrials.gov ID
- NCT04473924
- Acronym / sponsor ID
- STIFLE-RISK / 20-31500
- Conditions
- Infection, Transplant;Failure,Kidney
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has never started as sponsor did not approve for funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body surface area-based mycophenolate dosing | Experimental | Drug: Mycophenolate MofetilIntervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing. |
| Standard (fixed) dosing | Active comparator | Drug: Mycophenolate MofetilActive comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
- Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit
Key exclusion criteria (10 listed)
- Evidence of rejection on routine six month post-transplant biopsy
- Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
- Are or are planning to become pregnant, due to inability to take mycophenolate
- Are marginally housed, due to concerns regarding routine follow-up
- Are actively participating in a different interventional trial that may affect immunosuppression dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate MofetilAlso: CellceptBody surface area-based dosing of mycophenolate | Drug | Body surface area-based mycophenolate dosing |
| Mycophenolate MofetilAlso: CellceptStandard (fixed) dosing of mycophenolate | Drug | Standard (fixed) dosing |
Primary outcome
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
Time frame: 6 months
Assess the ratio of participants screened to enrolled into the study
4 secondary outcomes
Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate
Time frame: 6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Time frame: 6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Time frame: 6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Ku, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycophenolate Mofetil in people with Infection and Transplant;Failure,Kidney, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.